So many research projects are underway for vaccines or therapies for SARS-CoV-2 that there are concerns over getting suitable trial patients; it seems foreordained that there will be duplicative efforts and perhaps contradictory findings. A further complication, much commented on in the research arena for trials generally, is that travel and movement restrictions have made conventional clinical-trial practices extremely difficult: patients can’t, or won’t expose themselves to the risks of going to a clinic or hospital as part of a trial protocol.
The research community, and the vendors that serve it, have responded to these difficulties. One notable action comes from TransCelerate, the eight-year-old consortium of leading biopharma companies to pool research efforts. In 2017, TransCelerate had launched DataCelerate, a “cloud-based data sharing platform that allows for deidentified, anonymized pre-clinical and clinical data types to be requested and voluntarily shared.” Now, that platform is being opened to non-TransCelerate members; according to the group, eligible companies or research agencies “with proven human therapeutic clinical research, development and commercialization experience, who can properly manage data privacy and security, in alignment with both current TransCelerate Member Companies’ best practices and regulatory requirements” are eligible to participate.
According to Accenture, which provides the underlying technology to DataCelerate via its AIP+ analytics platform, “In other therapeutic areas, data shared via DataCelerate has already been used to reduce the number of patients in clinical trials, improve trial design, assess safety signals, increase knowledge of disease and treatments and improve the understanding of global patient populations.”
TranCelerate currently has 20 member companies, and is coordinating more than 30 initiatives to improve pharmaceutical research management.
Oracle expands data collection
To its Clinical One clinical-trial management system, Oracle Health Sciences has now added Clinical One Data Collection, which the company says “collects data from any source – forms, wearable sensors, patient apps, electronic health records (EHR), labs – and harmonizes it in a single place.” Earlier, the company also announced additional Clinical One services: its Clinical One Randomization and Supplies Management Cloud Service, which it says reduces the time required for study set up from nearly two months to just a few days. The company notes that Clinical One is already in use in trials focusing on Covid-19 vaccines and treatments.